{"entity":{"id":"acellular-dermal-matrix-breast","kind":"technology","name":"Acellular dermal matrices and meshes in implant reconstruction","aka":["Acellular dermal matrix","ADM","Biological mesh","SurgiMend","GalaFLEX","AlloDerm"],"tldr":"Sheets of processed animal or human skin, or absorbable synthetic mesh, used by surgeons to cover or support a breast implant or expander. The FDA has warned that complication rates differ between products.","summary":"Matrices and meshes reach the US market under general surgical mesh codes rather than for breast reconstruction specifically: TEI Biosciences' SurgiMend was cleared as surgical mesh (K083898, 4 February 2009, code FTM) and Tepha's GalaFLEX absorbable mesh as surgical film (K140533, 21 May 2014, code OOD). On 31 March 2021 the FDA issued a safety communication, now archived on its breast implant page, titled \"Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates\". In implant reconstruction the matrix forms a sling at the lower edge of the implant or wraps it completely when the implant sits in front of the chest muscle.","status":"established","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K083898: SurgiMend (4 February 2009)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083898"},{"label":"FDA 510(k) K140533: GalaFLEX mesh (21 May 2014)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140533"},{"label":"FDA: breast implants (safety communications and labeling guidance)","url":"https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["breast-cancer"],"sections":["surgery","devices"],"technologies":["breast-implants","breast-tissue-expanders","rejuv-recon-breast"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"principle":"A decellularised collagen scaffold or bioabsorbable polymer mesh is sutured to the chest wall and muscle to cover and position the implant while the patient's own tissue grows into it.","strengths":["Allows implant placement in front of the muscle","Supports the implant's position"],"limitations":["Complication rates differ between products (FDA, 2021)","Seroma and infection; adds cost"],"since":2009},"route":"/technologies/acellular-dermal-matrix-breast/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"breast-implants","kind":"technology","name":"Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)","route":"/technologies/breast-implants/"},{"id":"rejuv-recon-breast","kind":"technology","name":"Breast reconstruction: implant and autologous, immediate and delayed, and what women report afterwards","route":"/technologies/rejuv-recon-breast/"},{"id":"breast-tissue-expanders","kind":"technology","name":"Breast tissue expanders (saline and carbon dioxide)","route":"/technologies/breast-tissue-expanders/"}],"term":[{"id":"breast-reconstruction","kind":"term","name":"Breast reconstruction","route":"/terms/breast-reconstruction/"}]}}